This invention relates generally to the stopping of bleeding from blood vessels through openings in the vessel wall and more particularly through surgically produced punctures for different medical procedures.
Certain medical procedures require the percutaneous puncturing of a blood vessel to gain access to the interior of the vascular system of the patient for the procedure to be conducted. Procedures that commonly require such an percutaneous punctures are balloon angioplasty procedures, arteriography, venography, angiography and other diagnostic procedures that use blood vessel catheterization. Typically the percutaneous opening or puncture is made into a relatively large blood vessel such as a femoral artery. One of the difficulties in these procedures, however, is reclosure of the opening in the blood vessel wall after the procedure. In the past, manual pressure and/or mechanical clamping pressure have been used to physically hold the opening closed until a blood clot formed with sufficient strength to keep the opening blocked until healing takes place. More recently, several techniques have been used to insert a collagen plug in the tissue access passage to the blood vessel that promotes the formation of a coagulum at the vessel wall opening.
One such prior art technique simply inserts the collagen plug into the access passage in the tissue to the vessel wall puncture. The difficulty with this procedure is that there is no practical way to positively limit the protrusion of the collagen into the interior of the blood vessel. This sometimes results in the collagen being inserted or subsequently expanding through the blood vessel wall opening into the vessel lumen and causing a bloodclot to form in the interior of the blood vessel. This is undesirable because the clot and/or the protruding collagen can dislodge and move along the blood vessel to cause an embolus. Also, the clot formed at the interior end of the puncture site can serve to undesirably restrict the blood flow past the site (i.e. thrombosis).
Another technique is to insert a sealing plug through the opening in the blood vessel wall with a first orientation and then turned to an orientation such that it will not pass back out through the opening. The sealing plug is manipulated by a lanyard which extends back out through the tissue access passage exteriorly of the patient""s body to be manually held. The collagen plug is then passed down over the lanyard while the sealing plug is manually held in the blood vessel wall opening. Enough seepage of blood around the sealing plug is present to form the clot at the blood vessel wall opening. The sealing plug is left in position in the blood vessel wall and is made out of a material which is absorbable by the body over a several weeks or months period. The problem with this technique is that the sealing plug may break loose before it is absorbed by the body and cause a blockage of the blood flow through the blood vessel. The sealing plug may be a nidus for a blood clot to form and subsequently dislodge resulting in embolization. Another potential problem in leaving a device inside the vessel wall is that the device, like any foreign body, may erode the wall of the vessel or promote extensive intravascular scaring both of which potentially will disrupt vessel architecture.
These and other problems and disadvantages associated with the prior art are overcome by the invention disclosed herein by providing a technique for implanting a collagen plug in the tissue access passage to the percutaneous puncture or opening in a blood vessel which insures that the end of the plug does not extrude through the blood vessel wall opening into the blood vessel lumen. A tamponading means located inside the blood vessel lumen during installation of the collagen plug serves to positively prevent the collagen plug from being inadvertently pushed through the blood vessel wall opening as it is installed but which is removed after installation of the collagen plug so that no protrusion or other dislodgable material is left in the interior of the blood vessel after the procedure is completed. The tamponading means is selectively expandable to an expanded size and shape such that it will not pass back out through the blood vessel wall opening and its position in the blood vessel is controlled by a control member extending exteriorly of the patient for easy manipulation. For removal, however, tamponading means is selectively collapsible to a collapsed condition small enough to pass back out through the installed collagen plug without interfering with the coagulum forming capability of the collagen plug. The technique is simple to use and the location of the collagen plug is inherently accurately positioned at the blood vessel wall opening independently of variances in the patient""s skin and tissue thickness at the puncture site and without premeasuring or adjustment of the applicator.
The method of the invention is directed to the sealing a percutaneous puncture through a blood vessel wall comprising the steps of inserting a collapsed expandable tamponading member attached to a control member into the blood vessel lumen through the blood vessel wall puncture so that the control member extends out of the patient through the access passage to the skin surface; expanding the tamponading member to a size larger than the blood vessel wall puncture; pulling the expanded tamponading member back against the blood vessel wall opening using the control member to form a seal at the interior end of the blood vessel wall puncture; inserting a collagen plug into the access passage around the control member while the seal is maintained at the blood vessel wall puncture until the leading end of the collagen plug is located at the exterior end of the blood vessel wall puncture; then collapsing the tamponading member to the collapsed condition; and retracting the collapsed tamponading member back through the collagen plug. The collagen plug has a preformed passage therethrough which slidably receives the control member to allow placement of the collagen plug along the control member. The collagen serves to induce a coagulum that seals the outside end of the puncture in the blood vessel wall. After the collapsed tamponading member is pulled back through the collagen plug, the collagen plug self seals any opening through the plug left by the passage of the expandable member. The collagen plug may be housed in a retractable barrel while the collagen plug is inserted into the access passage and the barrel then retracted from around the collagen plug while maintaining the collagen plug in a substantially fixed position in the access passage. The barrel may be retracted fully or partially from around the collagen plug before the expanded tamponading member is collapsed and withdrawn. The method may also include visually indicating when the projecting end of the collagen plug is located at the exterior end of the blood vessel puncture. The collagen plug may also be backed up while the collapsed tamponading member is withdrawn through the plug to insure that the plug remains in place. The collagen plug may also be urged slightly toward the blood vessel wall puncture to compensate for any loss in volume of the collagen plug as it turns into a gelatinous mass.
The apparatus of the invention comprises a temporary sealing arrangement including an elongate flexible control portion small enough to pass through the blood vessel wall puncture with an expandable tamponading portion on the projecting end of the control portion collapsible to a condition smaller than the blood vessel wall puncture and expandable to a condition larger than the blood vessel wall puncture so that it will not easily pull back through the puncture. An applicator is provided to install the collagen plug in the access passage through the skin and tissue of the patient down to the exterior end of the blood vessel wall. The applicator cooperates with the control portion of the temporary sealing arrangement to fixedly locate the applicator with respect to the exterior end of the blood vessel wall and facilitate the positioning of the collagen plug with respect to the exterior end of the blood vessel wall puncture. The applicator includes a plug carrying assembly with a prescribed length used to insert the collagen plug. The control portion of the sealing arrangement includes indicia spaced a prescribed locating distance from that side of the expanded tamponading portion facing the puncture to provide a visual indication that the leading end of the collagen plug is located at the exterior end of the blood vessel wall puncture. The plug carrying assembly has an installation barrel defining a plug carrying chamber therein adapted to receive the collagen plug for installation in the access passage and a retraction arrangement is provided for selectively retracting the installation barrel from around the collagen plug while maintaining the plug at a substantially fixed position relative to the exterior end of the blood vessel wall puncture. The applicator may have a tightening mechanism for pulling the expanded tamponading portion of the temporary sealing arrangement tighter against the blood vessel wall puncture as the installation barrel is withdrawn from around the collagen plug. The applicator may also have an urging mechanism for urging the exterior end of the collagen plug toward the blood vessel wall with a slight force just sufficient to offset volume loss as the collagen plug softens to a gelatinous mass on contact with body fluids. This is especially true while the collapsed tamponading member is being withdrawn. The expanded tamponading portion of the sealing arrangement may be an inflatable balloon with an inflation lumen through the control portion for use in selectively inflating the balloon to the expanded condition.
These and other features and advantages of the invention will become more clearly understood upon consideration of the following detailed description and accompanying drawings wherein like characters of reference designate corresponding parts throughout the several views and in which: